At Nextern, we inspire with passion, impact with significance, and act with integrity.. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. From single-use disposables to fully integrated systems to precision components, our teams work as an extension of yours to solve patient needs and improve lives worldwide.
We are seeking an Manufacturing Equipment Engineer II to own the equipment and inspection-equipment lifecycle for our manufacturing lines — equipment specifications and drawings, preventive maintenance, fixture and tooling ownership, and the selection and qualification of new equipment, including precision dimensional metrology such as laser micrometers.
Responsibilities:
- Own and maintain equipment specifications, drawings, and documentation for production equipment, fixtures, and tooling; keep drawings synchronized with the as-built/as-run configuration and clear known documentation backlog items
- Build and run a preventive maintenance (PM) program for line equipment in partnership with Technicians, including PM schedules and spare-parts planning, with a clear escalation split between mechanical failures (Technician-owned first) and process issues (Engineering-owned first)
- Own fixture and tooling design, qualification, and lifecycle management, including revisions driven by process or product changes
- Lead specification, vendor evaluation, and qualification of new inspection and metrology equipment (e.g., laser micrometers and other dimensional gauging), including measuring-range and accuracy trade-off analysis, cross-vendor comparison, and fixture compatibility
- Support Test Method Validation (TMV) and equipment IQ/OQ/PQ activities, including Gage R&R studies, right-sizing validation effort to risk (CSA principles) in partnership with Quality
- Maintain a prioritized equipment-sustaining backlog with a defined update cadence; escalate long-lead capital equipment and qualification needs
- Partner with Manufacturing Engineering on root-cause investigations where equipment is a suspected contributing factor to scrap, yield loss, or line-down events
Requirements
Required:
- Bachelor’s degree in a STEM related field
- 3+ years of engineering experience owning production equipment, fixtures, or tooling in a regulated manufacturing environment
- Experience specifying and qualifying precision metrology or inspection equipment
- Experience with equipment/process validation (IQ/OQ/PQ) and test method validation (TMV), including Gage R&R methodology
- Working knowledge of GD&T, mechanical drawings, and CAD review (SolidWorks or similar)
- Familiarity with FDA 21 CFR Part 820 (Quality System Regulation) and ISO 13485, including design and equipment controls
- Understanding of validation documentation requirements in a regulated medical device environment
Preferred:
- Medical device experience
- Direct experience with laser micrometer / non-contact dimensional gauging systems (e.g., Mitutoyo, Keyence, LaserLinc, or similar) laser welders, HIPOT/ electrical safety equipment, Oscilloscopes, Hotbox and reflow towers and other calibration required manufacturing equipment,
- Experience building or formalizing a preventive maintenance program from an informal/ad hoc state preferred
- Experience in a catheter, balloon, or similarly high-precision disposable medical device manufacturing environment
- CMfgE, CQE, or similar professional certification
Salary Range:
$95,000 to $110,000 based on skills and experience
Benefits
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan with Company Match
- Paid Time Off, Personal Days, AND Birthday Holiday!
- Lifetime Membership Subsidy and Wellness Resources
- Life Insurance (Basic, Voluntary & AD&D)
- Family Leave (Maternity, Paternity)
- Short-Term & Long-Term Disability
- Taco Thursdays!!!
Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Skills Required
- Bachelor's degree in Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, or a related technical field
- 3-5 years of engineering experience owning production equipment, fixtures, or tooling in a regulated manufacturing environment
- Experience specifying and qualifying precision metrology or inspection equipment
- Experience with equipment/process validation, including IQ/OQ/PQ, and test method validation with Gage R&R methodology
- Working knowledge of GD&T, mechanical drawings, and CAD review
- Familiarity with FDA 21 CFR Part 820 and ISO 13485, including design and equipment controls
- Understanding of validation documentation requirements in a regulated medical device environment
- Direct experience with laser micrometer or non-contact dimensional gauging systems
- Experience building or formalizing a preventive maintenance program from an informal or ad hoc state
- Experience in catheter, balloon, or similarly high-precision disposable medical device manufacturing
- Medical device experience
- Experience with laser welders, HIPOT/electrical safety equipment, oscilloscopes, hotbox and reflow towers, or other calibration-required manufacturing equipment
- CMfgE, CQE, or similar professional certification
What We Do
Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.
